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ServiceUpdated on 31 July 2025

U–Mexico Contract Analytical & Stability Testing for Pharma & Biotech

Evaristo Urzua

Tech Transfer Liaison at CIATEJ

GUADALAJARA, JALISCO, Mexico

About

Partner with a Mexican public biotech research center to accelerate your Mexico market entry. We deliver contract analytical chemistry and microbiology services for pharma and biotechs: method development/validation, impurity profiling, and stability studies aligned with international guidelines. Core instrumentation includes HPLC, LC-MS/MS, GC-MS, ICP-OES, and spectroscopy; plus PCR/qPCR and microbiological assays for quality and safety.

What you get

  • Fit-for-purpose methods and validated reports (EN/ES).

  • Data packages suitable for COFEPRIS submissions and tech transfer.

  • Traceable raw data and clear SOPs for reproducibility.

How we work

  1. Rapid scoping call (EU-friendly hours) and NDA/MTA as needed.

  2. Tech transfer and sample plan; defined milestones and turnaround.

  3. Execution with QA review and interim readouts.

  4. Final dossier: raw data, statistical analysis, and regulatory-ready report.

Add-ons

  • Pilot-scale fermentation and microencapsulation for scale-up.

  • Tailored training for technical teams and practical consultancy (process, quality, and regulatory in Mexico).

Organisation

CIATEJ

Research organization

Guadalajara, Mexico

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